Clinical Effect of Electroacupuncture on Postoperative Analgesia After Cesarean Sectionanalgesia After Cesarean Section

September 17, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Clinical Effect of Electroacupuncture Combined With Fentanyl Patient-controlled Intravenous Analgesia on Postoperative Analgesia After Cesarean Section

Cesarean section is one of the most common operations in obstetrics. A survey shows that the rate of cesarean section in China is more than 40%, and even more than 70%. At present, the main analgesia methods after cesarean section are: patient controlled intravenous analgesia (PCIA), single injection of opioids into spinal canal, nerve block technique, combined or single oral drug for postoperative analgesia, etc. All kinds of postoperative analgesia methods have their own advantages and disadvantages. At present, PCIA is widely used in clinic, but it can cause side effects such as pruritus, nausea, vomiting and respiratory depression. Therefore, it is urgent to find a safe, effective, economic, reliable and operable treatment of PCIA for postoperative analgesia after cesarean section. Electroacupuncture is a technology combining traditional acupuncture and modern electrotherapy, which has a significant effect on acute and chronic pain. Studies have confirmed that electroacupuncture can help parturient women to deliver and relieve pain after delivery. However, there are few studies on the analgesic effect of Electroacupuncture on pain after cesarean section, and there are a few reports on wrist ankle acupuncture. On the basis of our previous research, we found that the frequency of 20 / 100Hz and 2Hz were the best for EA analgesia, and the density wave. Electroacupuncture is an ideal choice for PCIA analgesia after cesarean section because of its low price, rapid onset, long duration and no adverse drug reactions. "Zusanli" belongs to the stomach meridian of Foot Yangming. It is the meridian of multi Qi and multi blood. It has the effect of regulating meridians and collaterals, dredging Qi and blood, and treating various kinds of abdominal pain. Sanyinjiao belongs to the spleen meridian of foot Taiyin, which is the meeting of foot Taiyin, Jueyin and Shaoyin. Since ancient times, Sanyinjiao has been a commonly used acupoint to relieve labor pain. Modern studies have also shown that Sanyinjiao can relieve uterine contraction pain by relieving uterine smooth muscle spasm, improving the state of uterine ischemia and hypoxia, releasing a variety of central analgesic substances and so on Spleen and blood, liver tonifying and kidney tonifying. Therefore, on the basis of conventional PCIA analgesia combined with electroacupuncture at Zusanli and Sanyinjiao, we may play an auxiliary role in analgesia for puerpera after cesarean section.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Electroacupuncture is an ideal choice for PCIA analgesia after cesarean section because of its low price, rapid onset, long duration and no adverse drug reactions. "Zusanli" belongs to the stomach meridian of Foot Yangming. It is the meridian of multi Qi and multi blood. It has the effect of regulating meridians and collaterals, dredging Qi and blood, and treating various kinds of abdominal pain. Sanyinjiao belongs to the spleen meridian of foot Taiyin, which is the meeting of foot Taiyin, Jueyin and Shaoyin. Since ancient times, Sanyinjiao has been a commonly used acupoint to relieve labor pain. Modern studies have also shown that Sanyinjiao can relieve uterine contraction pain by relieving uterine smooth muscle spasm, improving the state of uterine ischemia and hypoxia, releasing a variety of central analgesic substances and so on Spleen and blood, liver tonifying and kidney tonifying. Therefore, on the basis of conventional PCIA analgesia combined with electroacupuncture at Zusanli and Sanyinjiao, we may play an auxiliary role in analgesia for puerpera after cesarean section.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 22-40 years old, gestational age 31-42 weeks;
  • There was no electroacupuncture treatment before cesarean section;
  • No food and drug allergy, no long-term use of analgesics; .They agreed and only participated in one clinical project and signed the informed consent form.

Exclusion Criteria:

  • Suffering from complications after cesarean section, such as massive hemorrhage, etc;
  • There was a history of chronic pain before operation;
  • History of cognitive impairment;
  • Skin lesions such as ulcers and eczema at the needling site are not suitable for needling;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PCIA +Acupuncture group
Acupuncturing bilateral Zusanli (ST36) and Sanyinjiao (SP6) to connect Huatuo brand electroacupuncture apparatus, but no electricity. Acupuncture was given once a day. PCIA（patient controlled intravenous analgesia）.
Other: PCIA +Acupuncture group:
Acupuncturing bilateral Zusanli (ST36) and Sanyinjiao (SP6)
Other Names:
  • PCIA +2 Hz Electroacupuncture group
  • PCIA +20/100 Hz Electroacupuncture group
Experimental: PCIA +2 Hz Electroacupuncture group
Acupuncture bilateral Zusanli (ST36) and Sanyinjiao (SP6) to connect Huatuo brand electroacupuncture apparatus, and the ipsilateral Zusanli, Sanyinjiao were respectively connected as a loop. The parameters of electroacupuncture were set as 2Hz, continuous wave, 25min, and current intensity was 0.1-5.0mA. Acupuncture was given once a day.
Other: PCIA +Acupuncture group:
Acupuncturing bilateral Zusanli (ST36) and Sanyinjiao (SP6)
Other Names:
  • PCIA +2 Hz Electroacupuncture group
  • PCIA +20/100 Hz Electroacupuncture group
Experimental: PCIA +20/100 Hz Electroacupuncture group
Acupuncture bilateral Zusanli (ST36) and Sanyinjiao (SP6) to connect Huatuo brand electroacupuncture apparatus, and the ipsilateral Zusanli, Sanyinjiao were respectively connected as a loop. The parameters of electroacupuncture were set as 20 / 100Hz, density wave, 25min, and current intensity was 0.1-5.0mA. Acupuncture was given once a day.
Other: PCIA +Acupuncture group:
Acupuncturing bilateral Zusanli (ST36) and Sanyinjiao (SP6)
Other Names:
  • PCIA +2 Hz Electroacupuncture group
  • PCIA +20/100 Hz Electroacupuncture group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of times PCIA is used
Time Frame: 48 hours after operation
Number of times PCIA is used
48 hours after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ying Jin, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-1029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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